Tuesday, March 6, 2018

The observations related to equipment and cleanliness, employees training, quality control and computer controls, according to the U.S. Food and Drug Administration’s Form 483 reviewed by GmpViolations.com

Observation 1:

Aseptic processing areas are deficient regarding system for maintaining any used to control the equipment aseptic conditions?

During inspection the FDA inspector has observed the un-cleaned debris material on the Filling machine and inspector has informed to the respective personnel on the spot, however next day, the same has been observed and filling carried out with dirty equipment (without cleaning).

Observation 2:

Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, Quality or Purity of the drug product.

This can be concluded that the operators are failed to follow c-GMP practices or the written procedures as the Equipment or its utensils must clean and must do follow sanitize in early interval. The Inspector has expected the good aseptic practices and ensure the Product SISPQ.

Observation 3:

Equipment used in the manufacture, processing, packing or holding of Drug products is not appropriate design to facilitate operations for its intended use.

The Vial washer Qualification with inspected Vial presentation not adequate, Example Vial washer failed to demonstrate if vail washer is able to remove bioburden from glass vials that are used for filling. Failed to use statistically sound number of vials to demonstrate the effectiveness of the wash cycle and processes.

“The Batch size selected for cleaning process Qualification is not appropriate as the it was 1% of actual batch size.

“The Batch size selected for endotoxin verification is not appropriate as the it was 1% of a commercial lot size.

Observation 4:

Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.

During Inspector walk-through of the facility a large mosquito has appeared inside the room, semi-finished product storage area holding. This room is located inside the unclassified but controlled environment corridor and is connected sets of doors. This room is two sets of doors away from the grade-B and grade “A” areas where the filling and activities for injection takes place.

Observation 5:

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Here it was concluded that failed to demonstrate the efficacy of the cleaning process, which is part of your cleaning activities, to eliminate contaminants in the hard to reach area in the aseptic fill and areas (grade A &B)

Observation 6:

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Observation 7:

The statistical quality control criteria fail to include appropriate acceptance levels and rejection levels.

The procedure for receiving and inspection of the components and packaging materials, (sampling of pacing materials) follows an unspecified level of AQL of with no clear criteria for acceptance and rejection level. This procedure is deficient to provide clear reject and acceptance levels.

Observation 8:

Established laboratory control mechanisms are not followed and documented at the time of performance.

Laboratory control is deficient in that____ USP reference standards, code # with lot #.. used to determine the identity, strength, quality and purity of drug injection which were received in laboratory.

And were not received in laboratory inventory management system (LIMS) as required by your procedure, however they were stored in the same container as other standards which were previously received and were in use.

Were not placed in desiccator as it is recommended on the COA.

Observation 9:

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorised personnel.

Master batch records that are submitted in #___ for __ injection, have different batch codes (document number) than the batch records that are currently in use for commercial production and master batch records that are submitted.

Job Description:

Job Summary

To plan, organize, direct and control manufacturing and related operations of large scale regulated Formulation / Pharmaceutical Manufacturing site, catering to the needs of USFDA, MHRA, KFDA, TAG, WHO markets

1. Preparation & execution of annual production budget, CAPEX. Support the product requirements of all marketing and sales divisions to ensure that products are produced according to plan 2. Maintain appropriate inventory levels. 3. Manage production expenses and maintain or reduce COGS. 4. Responsible for maintaining quality standards to meet GMP requirements. 5. Look after the FDA, MHRA, WHO and other regulatory Audits of the manufacturing facilities and processes. 6. Interface with the statutory bodies and ensure statutory compliance.7. Lead and manage major projects project for new as well as improving the existing ones8. Manage good industrial relations , build an effective team for sustainable & superior performance

Job Description (KRAs)-

Policies and Procedures: Direct and coordinate plant operations within company policies and procedures. Establishes and directs plant policies and procedures

Productivity:

Accountable for meeting plant production goals set by the VP manufacturing through the manufacturing budget process.Review, analyze, plan, coordinate and lead all activities within the manufacturing operations organization. Assure the development and coordination of systems and programs to promote cost effective manufacturing operations in line with manufacturing plans and objectives.Support programs and procedures that provide reliable products with minimal quality control, repair, scrap and warranty expense. Assures attainment of programs and production schedules while insuring high quality standards.

Quality:

Accountable for product quality control for the plant.

Planning:Develops and executes capital and expense budgets and operating plans under the guidance of General Manager.Schedule and conduct plant meetings.Initiate plans and processes which minimize manufacturing costs through effective utilization of manpower, equipment, facilities, materials and capital.Assure development and execution of manufacturing schedules in conjunction with the Materials Manager.Plan and implement manufacturing strategies and action plans to insure that the manufacturing operations group supports the strategic imperatives.Monitor plant performance and communicate progress against objectives to management.Confer with department heads to ensure coordination of sales and purchasing and logistics planning functions with site production, maintenance, and shipping groups.

Relationship Management:Partner with department heads to ensure coordination of purchasing, production, and shipping. Responsible for the smooth work flow process across these functional areas to ensure optimal performance and reduced errors.Communicate with local community.Network with Industry association counterparts

Product Development:Assure timely and efficient introduction of new and improved products, to ensure manufacturing input to product strategic plans.Coordinates with R&D and Engineering groups to implement new products and equipment.Communications & Working Relationships

Desired Profile:

B.Pharma/M.Pharma with 20-25 years of manufacturing experience in Formulation industry covering operations, maintenance, quality control and good manufacturing practices.

Must have 5-6 years of overall plant management experience with proven leadership record.

Plant management experience in a plant having more than 600 employees in last two jobs.

Experience of managing relations with government agencies.

Proven ability to direct and lead plant operations to drive production results. Independent, passionate in their work, customer focused and safety oriented.

Education:UG -Graduation Not Required, Any Graduate - Any SpecializationPG - Post Graduation Not Required, Any Postgraduate - Any SpecializationDoctorate - Doctorate Not Required, Any Doctorate - Any Specialization

Company Profile:

Established in 1995 Ind-Swift has fast evolved towards a business model that is focused on deep-rooted domestic presence and leveraged on high-value mature regulated markets along with considerable growth in emerging markets:* Ind-Swift Laboratories Ltd. (Manufacturer of APIs)* Ind-Swift Laboratories Inc. (US Subsidiary)With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry.

Job Description

1. Responsible for GMP/QMS/Hygiene/Good documentation practices compliance for area of assigned activity.2. To remain all time alert and responsible to ensure truthfulness of data for area of assigned activity as doer or checker..3. Responsible for preparation and archival of APQR (Annual Product Quality Review).4. Responsible for approval and distribution of shade card.5. Responsible for sending the couriers ( National & International ).6. Responsible for review of BMR and BPR.7. Responsible to ensure he is trained and qualified for the activities of assigned responsibility.8. To strictly follow master documents (BMR,BPR,QSD)instructions. In case of any issue raise deviation /change control for investigation and taking remedial action.9. Any other job assigned time to time as and when required.

Desired Profile:

Company Profile:

The Ace unit of Ind Swift Limited was created in the year 2005 with an aim to globalize the Ind Swift brand for finished dosage forms. The manufacturing site catering to the demand of the developed international markets was commissioned in 2006. A record was created when two major regulatory approvals, one from MHRA, UK and the other from TGA, Australia were received for this site within a record time of the site being commissioned. The approvals opened the gates for GBU to become a key supplier of products to the countries of EU, Australia, Canada, Singapore etc.